A Study of Nilotinib Versus Imatinib in GIST Patients (ENESTg1)

May 10, 2016 updated by: Novartis Pharmaceuticals

A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

644

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1264AAA
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1426ANZ
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000PBH
        • Novartis Investigative Site
  • Austria
      • Graz, Austria, 8036
        • Novartis Investigative Site
      • Leoben, Austria, A-8700
        • Novartis Investigative Site
      • Wels, Austria, 4600
        • Novartis Investigative Site
      • Wien, Austria, A-1090
        • Novartis Investigative Site
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Novartis Investigative Site
  • Brazil
    • MG
      • Uberlândia, MG, Brazil, 38408-150
        • Novartis Investigative Site
    • SC
      • Florianopolis, SC, Brazil, 88034-000
        • Novartis Investigative Site
    • SP
      • Campinas, SP, Brazil, 13083-970
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 04023-900
        • Novartis Investigative Site
  • Bulgaria
      • Sofia, Bulgaria, 1784
        • Novartis Investigative Site
      • Varna, Bulgaria, 9010
        • Novartis Investigative Site
  • Canada
      • Quebec, Canada, G1R 2J6
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Novartis Investigative Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5G1X5
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H3A 1A1
        • Novartis Investigative Site
  • China
      • Beijing, China, 100036
        • Novartis Investigative Site
      • Guangzhou, China, 510060
        • Novartis Investigative Site
      • Shanghai, China, 200032
        • Novartis Investigative Site
      • Shanghai, China, 200433
        • Novartis Investigative Site
    • Beijing
      • Beijing, Beijing, China, 100730
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Novartis Investigative Site
  • Colombia
      • Pereira, Colombia
        • Novartis Investigative Site
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
        • Novartis Investigative Site
  • Denmark
      • Herlev, Denmark, DK-2730
        • Novartis Investigative Site
      • Århus C, Denmark, DK-8000
        • Novartis Investigative Site
  • Egypt
      • Alexandria, Egypt
        • Novartis Investigative Site
      • Cairo, Egypt
        • Novartis Investigative Site
  • France
      • Bordeaux, France, 33076
        • Novartis Investigative Site
      • Chambray-lès-Tours, France, 37170
        • Novartis Investigative Site
      • Lyon Cedex, France, 69373
        • Novartis Investigative Site
      • Marseille Cedex 05, France, 13385
        • Novartis Investigative Site
      • Paris Cedex 13, France, 75651
        • Novartis Investigative Site
      • Saint-Herblain Cédex, France, 44805
        • Novartis Investigative Site
      • Toulouse Cedex 4, France, 31054
        • Novartis Investigative Site
      • Vandoeuvre les Nancy, France, 54511
        • Novartis Investigative Site
      • Villejuif Cedex, France, 94805
        • Novartis Investigative Site
  • Germany
      • Bad Saarow, Germany, 15526
        • Novartis Investigative Site
      • Duesseldorf, Germany, 40479
        • Novartis Investigative Site
      • Essen, Germany, 45122
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Mannheim, Germany, 68167
        • Novartis Investigative Site
      • Muenchen, Germany, 81377
        • Novartis Investigative Site
      • Weiden, Germany, 92637
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong SAR, Hong Kong
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1097
        • Novartis Investigative Site
      • Budapest, Hungary, 1062
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel, 3525408
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5266202
        • Novartis Investigative Site
  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • Novartis Investigative Site
    • FG
      • San Giovanni Rotondo, FG, Italy, 71013
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italy, 50134
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16132
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20133
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italy, 41100
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italy, 90127
        • Novartis Investigative Site
    • PN
      • Aviano, PN, Italy, 33081
        • Novartis Investigative Site
    • TO
      • Candiolo, TO, Italy, 10060
        • Novartis Investigative Site
      • Torino, TO, Italy, 10153
        • Novartis Investigative Site
  • Japan
      • Gifu, Japan, 501-1194
        • Novartis Investigative Site
      • Osaka, Japan, 540-0006
        • Novartis Investigative Site
      • Toyama, Japan, 930-0194
        • Novartis Investigative Site
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Novartis Investigative Site
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japan, 812-8582
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo-city, Hokkaido, Japan, 060-8648
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Novartis Investigative Site
    • Kumamoto
      • Kumamoto City, Kumamoto, Japan, 860-8556
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city, Miyagi, Japan, 980-8574
        • Novartis Investigative Site
    • Niigata
      • Niigata-city, Niigata, Japan, 951-8520
        • Novartis Investigative Site
    • Okayama
      • Kurashiki, Okayama, Japan, 701-0192
        • Novartis Investigative Site
    • Osaka
      • Suita-city, Osaka, Japan, 565-0871
        • Novartis Investigative Site
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Novartis Investigative Site
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Novartis Investigative Site
  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 443-380
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 05505
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 06351
        • Novartis Investigative Site
  • Mexico
      • Chihuahua, Mexico, 31000
        • Novartis Investigative Site
    • Distrito Federal
      • México, Distrito Federal, Mexico, 14080
        • Novartis Investigative Site
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Novartis Investigative Site
  • Netherlands
      • Leiden, Netherlands, 2300 RC
        • Novartis Investigative Site
  • Norway
      • Oslo, Norway, NO-0310
        • Novartis Investigative Site
  • Poland
      • Kraków, Poland, 31-501
        • Novartis Investigative Site
      • Warszawa, Poland, 02-781
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 022328
        • Novartis Investigative Site
      • Cluj-Napoca, Romania, 3400
        • Novartis Investigative Site
      • Iasi, Romania, 700106
        • Novartis Investigative Site
    • Dolj
      • Craiova, Dolj, Romania, 200535
        • Novartis Investigative Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620036
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115478
        • Novartis Investigative Site
      • St. Petersburg, Russian Federation, 198255
        • Novartis Investigative Site
    • Tatarstan Republic
      • Kazan, Tatarstan Republic, Russian Federation, 420029
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119228
        • Novartis Investigative Site
      • Singapore, Singapore, 169610
        • Novartis Investigative Site
  • Slovakia
    • Slovak Republic
      • Bratislava, Slovak Republic, Slovakia, 83310
        • Novartis Investigative Site
  • South Africa
      • Cape Town, South Africa, 7500
        • Novartis Investigative Site
      • Johannesburg, South Africa, 2199
        • Novartis Investigative Site
      • Pretoria, South Africa, 0027
        • Novartis Investigative Site
      • Pretoria, South Africa, 0002
        • Novartis Investigative Site
      • Pretoria, South Africa, 0001
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Novartis Investigative Site
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Novartis Investigative Site
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Novartis Investigative Site
  • Sweden
      • Goteborg, Sweden, SE-413 45
        • Novartis Investigative Site
      • Linköping, Sweden, SE-581 85
        • Novartis Investigative Site
      • Lund, Sweden, SE-221 85
        • Novartis Investigative Site
      • Stockholm, Sweden, SE-171 76
        • Novartis Investigative Site
      • Umeå, Sweden, SE-901 85
        • Novartis Investigative Site
      • Uppsala, Sweden, SE-751 85
        • Novartis Investigative Site
  • Taiwan
      • Lin-Kou, Taiwan, 33305
        • Novartis Investigative Site
      • Niaosong Township, Taiwan, 83301
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
    • Taiwan, ROC
      • Taipei, Taiwan, ROC, Taiwan, 112
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Novartis Investigative Site
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
      • Khon Kaen, Thailand, 40002
        • Novartis Investigative Site
      • Songkla, Thailand, 90110
        • Novartis Investigative Site
  • Turkey
      • Adana, Turkey, 01330
        • Novartis Investigative Site
      • Ankara, Turkey, 06100
        • Novartis Investigative Site
      • Ankara, Turkey, 06500
        • Novartis Investigative Site
      • Balcova / Izmir, Turkey, 35340
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Novartis Investigative Site
      • Kartal, Turkey, 34890
        • Novartis Investigative Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Novartis Investigative Site
      • Glasgow, United Kingdom, G12 0YN
        • Novartis Investigative Site
      • London, United Kingdom, SW3 6JJ
        • Novartis Investigative Site
      • London, United Kingdom, NW1 2BU
        • Novartis Investigative Site
      • Manchester, United Kingdom, M20 4BX
        • Novartis Investigative Site
      • Newcastle-upon-Tyne, United Kingdom, NE7 7DN
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Birmingham Hematology and Oncology Associates
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4)
      • Duarte, California, United States, 91010-3000
        • City of Hope National Medical Center Regulatory Document
      • La Jolla, California, United States, 92093-0658
        • University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (2)
      • Los Angeles, California, United States, 90095
        • University of California at Los Angeles GI Oncology Program
      • Stanford, California, United States, 94304
        • Stanford University Medical Center Stanford Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Dept. of Univ. of Colorado
      • Greenwood Village, Colorado, United States
        • Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center Wash Hospital
    • Florida
      • Ocala, Florida, United States, 34474
        • Ocala Oncology Center Dept. of Ocala Oncology Center
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Medical Center Dept.ofKootenai Med.Ctr.
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Clinical Research Office (2)
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0944
        • University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, P.A. SC
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester Division of Hematology
    • New York
      • Troy, New York, United States, 12180
        • New York Oncology Hematology, P.C. NYOH Amsterdam
      • Troy, New York, United States, 12180
        • New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • University of Pennsylvania Medical Center CAMN107G2301
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Univeristy Ingram Cancer Ctr.
    • Texas
      • Bedford, Texas, United States, 76022
        • Texas Oncology, P.A. Tex Onc (2)
      • Dallas, Texas, United States, 75246
        • Texas Oncology Wichita Falls
      • Dallas, Texas, United States, 75390-8527
        • University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)
      • Houston, Texas, United States, 77030-4009
        • University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13)
      • San Antonio, Texas, United States, 78229
        • Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3)
  • Venezuela
    • Distrito Capital
      • Caracas, Distrito Capital, Venezuela, 1010
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:

    • have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study or
    • recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.
  2. At least one measurable site of disease on CT/MRI scan
  3. Performance status ≤ 2 (capable of self-care but unable to carry out any work)
  4. Normal organ, electrolyte and marrow function

Exclusion Criteria:

  1. Any prior anti-neoplastic therapy with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST whose disease requires therapy while awaiting entry to the study.
  2. Disease progression during adjuvant therapy with imatinib
  3. History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
  4. Impaired cardiac function

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nilotinib
nilotinib 400 mg twice a day
Drug: Nilotinib (AMN107)
ACTIVE_COMPARATOR: Imatinib
imatinib 400 mg once daily
Drug: imatinib (STI571)
Other Names:
  • Glivec/Gleevec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Progression Free Survival (PFS)
Time Frame: up to month 37
PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
up to month 37

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

November 4, 2008

First Submitted That Met QC Criteria

November 4, 2008

First Posted (ESTIMATE)

November 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMN107G2301
  • 2008-004758-34 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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